This invention is submitted in the name of the following inventor:
The assignee is Genesis Medical Technologies, a California corporation having an office in Sunnyvale, Calif.
1. Field of the Invention
This invention relates to treating menorrhagia, female urinary incontinence and other related uro-genital conditions.
2. Related Art
Female uro-genital tract disorders include menorrhagia (excessive uterine bleeding) and urinary incontinence. Although both menorrhagia and urinary incontinence cause much embarrassment, they frequently remain untreated.
Causes of menorrhagia include disorders within the uterus itself such as fibroids, and (more rarely) endometrial cancer. When a specific cause cannot be identified, the condition is termed dysfunctional uterine bleeding.
Causes of female urinary incontinence include disturbances in the complex interplay of anatomic structures that control continence such as hypermobility or intrinsic sphincteric deficiency. Hypermobility is a lack of anatomic stability caused primarily by weak surrounding tissue; intrinsic sphincteric deficiency is the inability of the urinary sphincter muscles to function properly as a valve or otherwise.
The known art of treating female uro-genital disorders includes a variety of different treatments. Treatments for menorrhagia include drug therapy, dilation and curettage (D and C), hysterectomy, myomectomy and hysteroscopic resection of the endometrium. Treatments for female incontinence include both maintenance measures (for example, diapers, pharmaceutical remedies, foley catheters, behavioral therapy and vaginal pessaries) and surgical treatments.
A first drawback to treatment of female uro-genital disorders involves the risks associated with the known art of surgical treatment of menorrhagia. Surgical approaches to the treatment of menorrhagia can be highly invasive, ineffective or high-risk procedures. In addition to causing sterility, procedures such as hysterectomy have a high complication rate, lengthy recovery time and place the patient at increased risk for osteoporosis. Procedures such as dilation and curettage are fertility-sparing, but are ineffective for removal of submucosal fibroids. Techniques such as hysteroscopic resection of the endometrium with ablation devices such as the electrode loop, the rollerball and the laser are highly technical and have only been adopted by a small number of highly trained gynecological surgeons.
A second drawback to the known art of treating female uro-genital disorders involves risks and inefficacy of surgical treatments of female urinary incontinence. Many of these treatments aim to (1) elevate and ensure support of the urethrovesical junction or (2) provide additional support to the bladderneck and associated structures by introducing bulking agents, foreign bodies and other substances. Most surgical treatments suffer from many of the same problems as do treatments of menorrhagia. Surgical treatment is not generally appropriate for all types of incontinence; it is particularly inappropriate for urge or mixed incontinence. Lastly, the support provided by bulking agents, foreign bodies and other substances tends to be very short term; such agents degrade and get absorbed into surrounding tissues, requiring retreatment.
A third drawback to the known art of treating female uro-genital disorders involves the relative inefficacy of maintenance approaches to urinary incontinence. These treatments all aim to provide a technique to help the patient deal with the condition and minimize lifestyle problems associated with incontinence. While these treatments may allow a patient to achieve a short-term measure of control, they do not remedy the underlying defect.
Accordingly, it would be advantageous to provide a method and system for treatment of female uro-genital disorders that is curative, easy to learn, requires only local or regional anesthesia, does not induce side effects and is not subject to drawbacks of the known art. This advantage is achieved in embodiments of an invention in which radiofrequency (RF) energy is applied to uro-genital tissues so as to cause shrinkage and remodeling, reshaping, bulking and other treatment effects.
This invention provides a method and system for the curative treatment of female uro-genital disorders by application of radiofrequency (RF) energy to targeted tissues. Application of this energy is selectively applied so as to ablate, tighten, shrink or reshape the tissue and thereby correct an unwanted condition.
A first embodiment of the invention involves using a radiofrequency generator and disposable treatment unit to deliver radiofrequency energy to the interior of the uterus, enabling a gynecologist or other medical personnel to coagulate the entire endometrium and upper layers of the myometrium in one short procedure that can be performed in a physician""s office or other outpatient setting using local or regional anesthesia.
A second embodiment of the invention involves using a radiofrequency generator and a disposable treatment unit bearing two to four relatively small needle electrodes. The electrodes are positioned in the middle third of the urethra and energy is applied, causing shrinkage of the circular external urethral sphincter muscle. The tiny sites of treated muscle resorb, remodel and shrink in the weeks that follow treatment, causing a circumferential tightening of the urethral sphincter muscle. This treatment is curative of stress urinary incontinence that is, at least in part, secondary to sphincter muscle deficiency.
A third embodiment of the invention also involves using a radiofrequency generator and a treatment unit bearing two to four relatively small U-shaped electrodes. This treatment unit includes an irrigation balloon that is immediately proximate to the U-shaped electrodes. As saline irrigation cools and protects the bladder muscosa, RF energy is delivered to the submucosal bladder outlet musculature and connective tissue. The tiny sites of treated muscle resorb, remodel and shrink in the weeks that follow treatment, causing a circumferential tightening of the bladder outlet and a subsequent improvement in urinary continence via both decreased bladder outlet mobility and increased proximal urethra filling pressures.
A fourth embodiment of the invention also involves using a radiofrequency generator. The difference between this embodiment and the other embodiments is that the RF energy is delivered to the anterior and posterior regions of the vaginal wall. This has the effect of tightening of vaginal walls so as to increase support of the bladder outlet, proximal and mid-urethra. Moreover, circumferential tightening of the vaginal wall may provide physical and psychological improvement in the area of sexual function.